This invention is related to the subject matter described and claimed in co-pending application Ser. No. 049,240 filed May 13, 1987, which is hereby incorporated by reference in its entirety. This invention relates to containers for receiving body fluid samples, and for containing those samples for subsequent examination to determine the presence or absence of disease in the samples. More particularly, this invention relates to such containers having incorporated therewith a standard dry chemistry test strip for testing for the presence and/or absence of a plurality of potential diseases, or other body conditions, in the sample introduced into the container.
Generally speaking, such containers are in tube form, and they may or may not be evacuated, depending upon the particular sample being taken. As will be understood by practitioners-in-the-art, evacuated tubes are used in great numbers for taking blood and urine samples, with the tubes containing reagents for reacting with the samples for determining in subsequent clinical tests the presence or absence of disease. The tubes may also be non-evacuated tubes for taking samples for one reason or another. Urine samples may be taken in both evacuated and non-evacuated tubes. While non-evacuated tubes are utilized in great numbers, it is preferred to use evacuated tubes for many specific applications for maintaining a seal of the tube prior to use and for facilitating the entry of the sample into the evacuated tube for subsequent testing of the sample.
In taking urine samples in the past, it has been conventional for the sample to be introduced into a cup or other open container. Subsequently, a dry chemistry test strip is introduced into the urine sample for examination to determine the presence or absence of diseases, or other conditions of the sample taken. These tests include, for example, pH, protein, glucose, ketone, bilirubin, blood, urobilinogen. However, in using such open containers, there is a risk that the sample will be contaminated prior to the testing taking place. Moreover, there is the danger that the person handling the sample will be contaminated in one way or another by exposure to the sample.
With this invention, by contrast, a test strip is incorporated into and made a part of the container assembly receiving a blood and/or urine sample for testing. That is, a conventional transparent tube, preferably plastic, has a plurality of bores through one portion of the wall thereof. Placed immediately adjacent each bore is a different dry chemistry test patch for individual tests. The patches are positioned to be immediately adjacent the bores in the tube so that when a sample is introduced into the tube, a portion of the sample passes through each of the bores and is absorbed into each of the adjacent individual test patches.
In this way, a plurality of tests for the presence or absence of conditions in the sample take place almost simultaneously with the introduction of the sample into the assembly. Moreover, the sample is maintained in an uncontaminated state in the tube proper so that a portion of the sample remains for further testing, if required.
The arrangement of invention here includes the utilization of a transparent shrink-wrap over the tube and the test strip so as to maintain the container in a sealed uncontaminated condition prior to use. Moreover, with the shrink-wrap in combination with the tube body and the test strip together with a conventional stopper on the tube, the container of the invention may be evacuated so as to facilitate later introduction of the sample into the tube. The tube is maintained in a sealed uncontaminated state until use so that the sample remains uncontaminated until all of the testing is completed.
The assembly of the invention herein utilizes a pre-shrunk film disposed over the outer surface of a tube or other container for taking a body fluid sample. That is, a film is pre-shrunk over the previously developed container. In this connection, the container may be glass or thermoplastic. A thermoplastic material is preferred because it is much simpler, and far less costly, to incorporate the bores utilized with the invention herein in a plastic tube as opposed to a glass tube.
At any rate, a test strip which may be a conventional dry chemistry strip such as "CHEMSTRIP 7L".TM. by Boehringer Mannheim Diagnostics or "MULTISTIX".TM. by Ames Division of Miles Laboratories may be incorporated into the structure in accordance with this invention. That is, the test strip may be placed so that the individual test patches having incorporated therein certain chemicals for reacting and indicating by color the presence or absence of disease or other condition in a urine sample are placed adjacent the bores in the tube container of the invention. Subsequently, the entire structure including the test strip is incorporated into the clear shrink-wrapped film as discussed above. By having the entire outer surface, or a substantial portion thereof, covered by a wrapped plastic film the plastic wrap around the tube contains the sample therein. Moreover, the plastic wrap shields the technician from any contamination from a sample by leakage or cracking of the container in some manner. Nevertheless, the response of each test patch is immediately visible once a sample is introduced into the container.
It will be understood that the tube may be evacuated or not evacuated in accordance with this invention. The presence of the film firmly adhering to the outer surface of a container and test strip holding a body fluid sample has the effect of maintaining the general integrity of the container so that it may be properly utilized and disposed of without any contamination to the user. Moreover, the wrap makes the container stronger overall because of the cushioning characteristics of the wrap.
As purely illustrative of a plastic film material which may be used as a shrink-wrap over a fluid specimen container in accordance with this invention, one may note that polyvinyl chloride, polyester copolymers or polystyrene films may be utilized for shrink-wrapping such containers. One particularly appropriate material is polyvinyl chloride film such as "SkinTight".RTM., a heat-shrinkable polyvinyl chloride film supplied by Gilbreth International Corporation, Bensalem, Pa. 18020. Such polyvinyl chloride films obtain the desired shrinking property by first being extruded, followed by then holding and restraining one dimension of the film while cooling the material, and not restraining the other dimension thereof. This has the effect of pre-stressing the material in the direction which it is held. Subsequently, with the application of heat, the material will then shrink about five to ten percent in the direction not held or restrained while shrinking about fifty-five to seventy-five percent in the pre-stressed direction so that it "shrinks-down" onto the vessel being covered.
It may be appropriate to apply a heat-activated adhesive to the inner surface of the film which will adhere to the vessel being encompassed by the shrink-down film. The heat-activated adhesive may be printed or applied to the inner surface of the film and when the film is heated for shrink-down onto the container, the adhesive becomes activated and helps adhere the film to the object being wrapped. Any conventional heat-activated adhesive may be used for such application.
As a further feature of the invention, the shrunk-down film may be applied to an evacuated container, for example, once the stopper therefor has been put into place and the vacuum applied, holding the stopper in a sealed position. Subsequent application of the plastic wrap which is to be shrunk-down may be over both the container itself and it may extend up and over the stopper. By doing so, a further sealing of the stopper tube interface takes place.
A registered serration may be incorporated into the shrink film at the stopper/glass interface in order to develop a tamper-proof closure. This may be appropriate for drug abuse testing, as well as specimen identification and quality control.
Printing may be placed on either side of the shrinkable tube of film material which is to be shrunk-down onto the container of interest. For example, a product identification, brand name, or company logo may all be included on the inner or outer surface of the film prior to introduction onto the container. Also, a matte finish or a corona discharge surface may be developed on the outer surface of the film to be shrunk onto the container so as to make the surface appropriate for receiving subsequently added written identification information for a sample contained in the container. Furthermore, pressure sensitive adhesive labels may be placed on the outer surface of the shrunk-down film so as to accommodate various hospital over-labels, for example.
With the foregoing and additional objects in view, this invention will now be described in more detail, and other objects and advantages thereof will be apparent from the following description, the accompanying drawings, and the appended claims.
As purely illustrative of an arrangement of wrapped container which may be used for carrying out this invention, one may note the attached drawings in which several embodiments of such a container are shown utilizing the wrapped container/dry chemistry strip combination feature of the invention .